To Evaluate the Safety and Efficacy of Human CD19 Targeted DASH CAR-T Cells Injection for Subjects With R/R B-ALL

Launched by HRAIN BIOTECHNOLOGY CO., LTD. · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is looking to test a new treatment called human CD19 targeted DASH CAR-T cells for patients with B-cell Acute Lymphoblastic Leukemia (B-ALL) who have not responded well to previous treatments. The goal is to see how safe this treatment is and if it can help patients who have relapsed or did not achieve remission after standard chemotherapy. The trial is currently recruiting participants aged between 18 and 70 years old, who have a specific type of B-ALL that tests positive for a marker called CD19.

Participants in the trial can expect to receive the new CAR-T cell therapy, which involves collecting their own immune cells, modifying them in a lab, and then infusing them back into their body to help fight the leukemia. To be eligible, individuals must have been diagnosed with B-ALL, have a life expectancy of more than 12 weeks, and meet certain health criteria, including functioning liver and kidney. It's important to note that patients with certain conditions, such as active infections or other serious health issues, will not be eligible for this trial. This study aims to provide valuable information about a potential new treatment option for those struggling with this aggressive form of leukemia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:Subjects must meet all of the following criteria to be enrolled:
• • 18 to 70 years old (including cut-off value), Male and female;
• • Expected survival \> 12 weeks;
• • ECOG score 0-1;
• * Bone marrow examination clearly diagnosed as B-cell acute lymphoblastic leukemia, CD19 positive, and who met one of the following conditions:
• • 1. Those who failed to achieve CR after at least 2 courses of standard chemotherapy or had early relapse after complete remission (\<12 months) or late relapse after complete remission (≥ 12 months) and failed to achieve CR after 1 course of standard chemotherapy;
• • 2. For Ph+ ALL: in addition to receiving at least 2 courses of standard chemotherapy, at least two TKIs should be treated with no complete remission or relapse after complete remission; (Patients who cannot tolerate TKI therapy or have TKI treatment contraindications or have T315i mutation are excluded);
• • 3. Those who relapse after stem cell transplantation are not affected by previous treatments;
• • The venous access required for collection can be established and leukapheresis can be carried according to the judgement of investigators;
• * Liver, kidney and cardiopulmonary functions meet the following requirements:
• • 1. Serum creatinine ≤ 1.5×ULN;
• • 2. Left ventricular ejection fraction \> 50%;
• • 3. Baseline oxygen saturation \> 96%;
• • 4. Total bilirubin ≤ 2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN (As judged by the investigator, the elevation of transaminase caused by the ALL disease itself, ALT and AST ≤ 5×ULN);
• • Able to understand and sign the Informed Consent Document.
• • Exclusion Criteria:Any one of the following conditions cannot be selected as a subject：
• • Graft-versus-host disease (GVHD), or need to use immunosuppressants after transplantation;
• • Patients with hyperleukocytosis (white blood cell count ≥ 50×10\^9/L) or whose disease progressed rapidly according to the investigator's judgment at the time of enrollment and cannot ensure the completion of a complete treatment cycle;
• • Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma in situ after radical resection and thyroid cancer after radical resection;
• • Subjects with positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer detection higher than the lower limit of the research center can detect; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis detection positive;
• • Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
• • Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
• • Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
• • Received CAR-T treatment or other gene therapies before enrollment;
• • Patients with symptoms of central nervous system;
• • Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use);
• • The investigators consider other conditions unsuitable for enrollment.

Trial Officials